ESTIM-UL: FES for Upper Limb Recovery After Stroke (ESTIM-UL)

March 30, 2026 updated by: Spina Stefania, University of Foggia

Efficacy of Functional Electrical Stimulation (FES) Combined With Task- Oriented Training on Upper Limb Recovery in Post-Stroke Patients With Spastic Hemiparesis: A Randomized Controlled Trial

Stroke is a leading cause of long-term disability, frequently resulting in impaired upper limb motor function and spasticity. Although Botulinum Toxin Type A (BoNT-A) is effective in reducing focal spasticity, functional recovery of the upper limb often remains limited without intensive, task-specific rehabilitation. Functional Electrical Stimulation (FES), when synchronized with voluntary movement during Task-Oriented Training, may enhance motor recovery by facilitating muscle activation and neuroplasticity. This randomized controlled trial aims to evaluate whether FES combined with Task-Oriented Training is superior to conventional Task-Oriented Training alone in improving upper limb function in post-stroke patients treated with BoNT-A.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke remains one of the leading causes of long-term disability worldwide. Among its most disabling and persistent sequelae is impairment of upper limb motor function, affecting approximately 50-80% of stroke survivors in the acute phase and persisting in a substantial proportion of patients over time. Incomplete recovery of manual dexterity and fine motor control significantly limits independence in activities of daily living and negatively impacts quality of life. A major factor limiting upper limb recovery after stroke is the development of spasticity, a sensorimotor disorder resulting from upper motor neuron lesions. Upper limb spasticity typically evolves toward pathological flexor synergies which, if left untreated, lead to increased muscle tone, altered muscle-tendon properties, soft tissue shortening, and fixed joint deformities. These changes interfere with voluntary motor control, functional use of the limb, hygiene, and caregiving.

Current international guidelines identify focal injection of Botulinum Toxin Type A (BoNT-A) as the first-line treatment for focal upper limb spasticity. By blocking presynaptic acetylcholine release at the neuromuscular junction, BoNT-A induces a temporary chemical denervation that effectively reduces muscle overactivity. However, clinical experience and scientific evidence consistently demonstrate a frequent dissociation between technical success, defined as reduction in spasticity scores, and functional success, defined as improved active use of the upper limb. Reduction of muscle tone alone, although necessary, is not sufficient to restore voluntary motor control in a damaged central nervous system unless it is integrated into an intensive neuromotor rehabilitation program.

This observation has led to the concept of a "therapeutic window," in which BoNT-A reduces peripheral biomechanical resistance, creating favorable conditions that must be exploited through targeted adjunctive rehabilitation therapies. Among these, Task-Oriented Training (TOT), based on repetitive and intensive practice of meaningful functional tasks, represents one of the most effective approaches to promote post-stroke neuroplasticity.

Nevertheless, in patients with moderate to severe paresis, insufficient voluntary muscle activation often limits the effective execution of task-oriented exercises.

In this context, Functional Electrical Stimulation (FES) emerges as a key rehabilitative technology. Beyond inducing muscle contraction through peripheral nerve stimulation, FES acts as a powerful modulator of cortical plasticity. When synchronized with the patient's voluntary movement attempts, FES provides enhanced somatosensory feedback to the sensorimotor cortex. The coupling of motor intention, assisted execution, and afferent feedback reinforces synaptic connections according to Hebbian learning principles. Despite a strong neurophysiological rationale, there remains a lack of rigorous randomized controlled trials quantifying the specific added value of FES when combined with task- oriented rehabilitation in patients treated with BoNT-A. The present study is based on the hypothesis that applying FES to wrist and finger extensor muscles during Task-Oriented Training, in post-stroke patients previously treated with BoNT-A to inhibit spastic flexor muscles, produces a synergistic effect superior to conventional task-oriented rehabilitation alone. By simultaneously reducing spasticity-related resistance and enhancing muscle recruitment and cortical plasticity, this multimodal approach is expected to result in greater improvements in manual dexterity and overall upper limb function.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Foggia
      • Foggia, Foggia, Italy, 71121
        • Università degli studi di Foggia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Diagnosis of ischemic or hemorrhagic stroke, documented by CT or MRI.
  • Clinical presence of focal upper limb spasticity, defined as a score ≥ 1+ on the Modified Ashworth Scale (MAS) in at least one target muscle group (elbow, wrist, or finger flexors), treated with Botulinum Toxin Type A injection.
  • Presence of residual voluntary muscle activation (minimal active movement) sufficient to initiate the motor task required by the training (Box and Block score > 1).
  • Preserved cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24 or clinical judgment confirming adequate comprehension and cooperation.

Exclusion Criteria:

  • Absolute contraindications to Functional Electrical Stimulation (FES), including the presence of a cardiac pacemaker or implantable cardioverter defibrillator (ICD), pharmacologically uncontrolled epilepsy, or skin lesions/dermatitis at the electrode application sites.
  • Presence of severe muscle-tendon contractures or fixed joint deformities (ankylosis) that mechanically limit passive movement and make active functional recovery unlikely.
  • Severe cognitive impairment, global aphasia, or severe unilateral spatial neglect that prevents task comprehension or active participation in the training program.
  • Concomitant orthopedic or rheumatologic conditions affecting the upper limb (e.g., recent fractures, severe arthritis) that could interfere with treatment delivery or outcome assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Electrical Stimulation plus Task-Oriented Training
Participants in the experimental arm receive Task-Oriented Training of the affected upper limb with Functional Electrical Stimulation (FES) applied to upper limb muscles based on the movement. FES is delivered using a wireless stimulation system and is synchronized with the participant's voluntary movement attempts to facilitate active motor execution. The first module includes active Task-Oriented Training of the paretic upper limb, such as reaching, grasping, and object manipulation. During task execution, Functional Electrical Stimulation is applied to upepr limb muscles and is synchronized with the participant's voluntary movement attempts to facilitate active motor execution and provide proprioceptive feedback.The second module consists of conventional physiotherapy focused on joint mobilization (passive and active-assisted movements) and muscle stretching. Each session lasts 60 minutes and is conducted 5 days per week for 2 consecutive weeks (10 sessions total).
Device: Functional Electrical Stimulation (FES)
Functional Electrical Stimulation is applied to wrist and finger extensor muscles of the paretic upper limb using a surface electrode system. Electrical stimulation is synchronized with the participant's voluntary movement attempts during Task-Oriented Training to facilitate active motor execution and sensorimotor integration. Stimulation is delivered during 60-minute rehabilitation sessions, 5 days per week for 2 consecutive weeks.
Active Comparator: Task-Oriented Training with Conventional Rehabilitation
Participants in the control arm receive Task-Oriented Training of the affected upper limb with conventional manual facilitation provided by a physiotherapist, without electrical stimulation. The first module includes Task-Oriented Training of the paretic upper limb, such as reaching, grasping, and object manipulation. When required, assistance to movement is provided manually by the physiotherapist through neuromuscular facilitation techniques, without Functional Electrical Stimulation. The second module consists of conventional physiotherapy focused on joint mobilization and muscle stretching, identical to that delivered in the experimental arm. Each session lasts 60 minutes and is conducted 5 days per week for 2 consecutive weeks (10 sessions total).
Other: Conventional Rehabilitation
Conventional rehabilitation consists of therapist-assisted Task- Oriented Training of the paretic upper limb, including manual facilitation and guidance as needed to support task execution. No electrical stimulation is applied. Sessions last 60 minutes and are performed 5 days per week for 2 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gross Manual Dexterity
Time Frame: Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Measured as the mean change in score on the Box and Block Test (BBT), defined as the difference in the number of blocks transferred in 60 seconds between baseline and post-treatment
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fine Manual Dexterity
Time Frame: Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Change in completion time on the Nine Hole Peg Test (NHPT), expressed in seconds. The NHPT measures fine manual dexterity; lower completion times indicate better performance.
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Upper Limb Muscle Strength
Time Frame: Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Change in upper limb muscle strength measured by the Motricity Index (MI) for the upper limb (score range: 0 to 100, with higher scores indicating greater muscle strength). The MI assesses strength at proximal, middle, and distal joints of the upper limb.
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Upper Limb Muscle Tone
Time Frame: Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Change in muscle tone measured by the Modified Ashworth Scale (MAS) (ordinal scale ranging from 0 to 4, with higher scores indicating greater spasticity), assessed in elbow, wrist, and finger flexor muscles.
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
EQ-5D-5L Index
Time Frame: Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Change in health-related quality of life measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive index (index value typically ranging from <0 to 1, with higher scores indicating better health status).
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
EQ-5D Visual Analogue Scale (VAS)
Time Frame: Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)
Change in self-rated health status measured by the EuroQol Visual Analogue Scale (EQ-5D VAS) (scale range: 0 to 100, with higher scores indicating better perceived health).
Baseline (T0, prior to randomization) to Post-Treatment (T1, within 24-48 hours after completion of the 2-week rehabilitation program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Foggia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FoggiaFisiatria02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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